Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Umbilical artery potential of hydrogen (pH)
研究概览
简要总结
Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.
详细描述
Hypotension often occurred in parturients undergoing cesarean section in spinal anesthesia. This study aims to determine whether preventive intramuscular phenylephrine can better the fetal acid-base state and maternal hemodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 40 years.
- •Elective cesarean section
- •American Society of Anesthesiologists (ASA) grade from I to Ⅱ, height from 150 cm to 180 cm, BMI<40kg/m2
- •Singleton pregnancy
- •Without pregnancy complications
排除标准
- •Multiple pregnancy
- •Preoperative bradycardia
- •Coagulation dysfunction
- •Parturients with hypertension, diabetes, eclampsia and other pregnancy complications.
研究组 & 干预措施
Intramuscular phenylephrine group
Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Phenylephrine (Drug)
Intramuscular phenylephrine group
Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Normal saline (Drug)
Intramuscular phenylephrine group
Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Bupivacaine (Drug)
Intravenous phenylephrine group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Phenylephrine (Drug)
Intravenous phenylephrine group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Normal saline (Drug)
Intravenous phenylephrine group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Bupivacaine (Drug)
Placebo group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Phenylephrine (Drug)
Placebo group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Normal saline (Drug)
Placebo group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Umbilical artery potential of hydrogen (pH)
时间窗: after the baby is delivered
detected by a blood gase analyzer
次要结局
- Umbilical venous partial pressure of oxygen (PaO2)(after the baby is delivered)
- Umbilical artery base excess(after the baby is delivered)
- Umbilical venous potential of hydrogen (pH)(after the baby is delivered)
- Umbilical venous base excess(after the baby is delivered)
- Umbilical venous lactate(after the baby is delivered)
- Umbilical venous glucose(after the baby is delivered)
- Incidence of fetal acidosis(after the baby is delivered)
- Umbilical artery partial pressure of carbon dioxide (PaCO2)(after the baby is delivered)
- Umbilical venous partial pressure of carbon dioxide (PaCO2)(after the baby is delivered)
- Umbilical artery lactate(after the baby is delivered)
- Incidence of hypotension(intraoperative)
- Umbilical artery partial pressure of oxygen (PaO2)(after the baby is delivered)
- Incidence of hypertension(intraoperative)
- Incidence of bradycardia(intraoperative)
- Umbilical artery glucose(after the baby is delivered)
- Incidence of nausea or vomit(intraoperative)
研究者
Chao Xu
Principal Investigator
Xuzhou Medical University